Drug factory · FDA FEI 1850039

Labcorp Early Development Laboratories Inc.

671 S. Meridian road, Greenfield, IN, United States

Problems found, fixed voluntarily at FDA's last inspection, Jul 25, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

3 drug inspections on record since 2016: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Obiltoxaximab	Tests it	Elusys Therapeutics, Inc.	69604-204

Ended	Result	Program	Problems noted
Jul 25, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	4
Nov 21, 2019	No problems found	Drug Quality Assurance	—
Jan 20, 2016	No problems found	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that conform to appropriate standards of identity, strength, quality and purity.
Testing in same container - closure system 21 CFR 211.166(a)(4)
The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Registered with FDA for: analysis.